PubMed | Tokyo Metropolitan Childrens Medical Center Tokyo, Baylor College of Medicine, University of Sheffield, Stanford University and 34 more.
Type: Journal Article | Journal: European journal of endocrinology | Year: 2016
The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH).A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues.Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.
Ding T.,Soochow University of China |
Ding T.,Wuxi Peoples Hospital |
Yang H.,Soochow University of China |
Maltenfort M.,Jefferson Medical College Philadelphia |
Xie R.,Soochow University of China
Case Reports and Clinical Practice Review | Year: 2010
As a bone cement in vertebroplasty and kyphoplasty, calcium phosphate cement (CPC) has several advantages over polymethylmethacrylate (PMMA) including biomcompatibility, biodegradability and osteoconductivity. However, its decay properties raise the risk of pulmonary embolism and consequent cardiovascular complications. Animal experiments have demonstrated that the disintegration of CPC forming more emboli, especially microemboli, causes more severe cardiovascular deterioration than PMMA. Current efforts focus on the incorporation of organic proteins or polymers into CPC to improve its stability in fluids, by enhancing the hydroxyapatite (HA) formation and reducing the fluid penetration. Silk fibroin (SF) can regular the mineralization process and bond with HA to form fibroin-HA nanocomposites with increased gelation properties. SF also has excellent biomechanical, biocompatible and biodegradable properties, and is convenient and inexpensive to produce. We hypothesize that silk fibroin can be used as an additive to improve the cohesion of CPC and decrease its risk of cardiovascular complications in its application in veterbroplasty/kyphoplasty. © Med Sci Monit.